Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions

Melanoma (Skin) Clinical Trial

Official title:

Development of an Electrical Diagnostic for Melanoma and Other Cutaneous Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00391300
• Other study ID #: CDR0000616117
• Secondary ID: EVMS-BFI and Les
• Status: Active, not recruiting
• Phase: Phase 1
• First received: October 2, 2006
• Last updated: December 17, 2013
• Start date: October 2006
• Est. completion date: April 2007

Study information

• Verified date: October 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: New diagnostic procedures, such as bioelectric field imaging, may help find and diagnose melanoma and other skin cancers. It may also be a less invasive way to check for skin cancer.

PURPOSE: This phase I trial is studying bioelectric field imaging in diagnosing melanoma and other skin cancers in patients with skin lesions.

Description:

OBJECTIVES:

• To determine if the hand-held Bioelectric Field Imager can be used to measure the electric field in skin of various body surfaces, including face, neck, shoulders, arms, hands, chest, back, legs, and feet, during the course of examination and treatment of patients with suspected malignant skin lesions.

• To determine if there is a significant difference between the lateral electric field strength near benign and malignant skin lesions in the same individual.

OUTLINE: Patients undergo scanning of their skin lesions and nearby healthy skin using the Bioelectric Field Imager (BFI). The lesions are then biopsied for histological diagnosis. Histological data from the biopsy is correlated with the electric field data from the BFI.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Suspected malignant skin lesion

• Seeking treatment for skin lesion at the VA Medical Center

PATIENT CHARACTERISTICS:

• Not pregnant

• No acute illness, including upper respiratory tract infection or flu that could result in fever

• No trauma to the skin lesion area

• No prisoners

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)
• Non-melanomatous Skin Cancer
• Skin Neoplasms

Intervention

Procedure:
• bioelectric field imaging

• biopsy

• histopathologic examination

Locations

Country	Name	City	State
United States	VA Hospital	Hampton	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Eastern Virginia Medical School	National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of Bioelectric Field Imager (BFI) in measuring the electric field in skin of various body surfaces			No
Primary	Use of BFI in detecting significant electric field differences between malignant and benign skin lesions			No